Barrel-shaped apparatus for fusing adjacent bone structure

ABSTRACT

A fusion implant apparatus for facilitating fusion of adjacent bone structures includes a threadless implant member which is positioned between adjacent opposed bone structures. The implant member defines a longitudinal axis and first and second longitudinal ends and has an outer wall which is dimensioned to engage the opposed bone structures upon positioning therebetween in supporting relation therewith. The outer wall defines an internal cavity for the reception of bone growth inducing substances and includes a plurality of apertures which extend therethrough in communication with the internal cavity to permit fusion of vertebral bone tissue. The implant member also includes an intermediate portion which defines a cross-sectional dimension transverse to the longitudinal axis which is greater than the respective cross-sectional dimensions of the first and second longitudinal ends of the implant member.

BACKGROUND

The present disclosure generally relates to a surgical apparatus forfusing adjacent bone structures, and, more particularly, to abarrel-shaped apparatus and method for fusing adjacent vertebrae.

TECHNICAL FIELD

The fusion of adjacent bone structures is commonly performed to providefor long-term replacement to compensate for vertebral subluxationtypically caused by severe trauma to the spine, degenerative ordeteriorated bone disorders, e.g., osteoporosis, abnormal curvature ofthe spine (scoliosis or kyphosis) and/or weak or unstable spineconditions typically caused by infections or tumors. In addition, anintervertebral disc, which is a ligamentous cushion disposed betweenadjacent vertebrae, may also undergo deterioration or degeneration as aresult of injury, disease, tumor or other disorders. The disk shrinks orflattens leading to mechanical instability and painful disctranslocations, commonly referred to as a “slipped disc” or “herniateddisc”.

Conventional procedures for disc surgery include partial or totalexcision of the injured disc portion, e.g., discectomy, and replacementof the excised disc with biologically acceptable plugs or bone wedges.The plugs are driven between adjacent vertebrae to maintain normalintervertebral spacing and to achieve, over a period of time, bonyingrowth or “fusion” with the plug and opposed vertebrae.

Alternatively, a metallic fusion cage may be inserted within a tappedbore or channel formed in the intervertebral space thereby stabilizingthe vertebrae and maintaining a pre-defined intervertebral space. A pairof fusion cages may also be implanted within the intervertebral space.After a period of time, the soft cancellous bone of the surroundingvertebral bone structures infiltrates the cage through a series ofapertures in the cage wall and unites with bone growth inducingsubstances disposed within an internal cavity to eventually form a solidfusion of the adjacent vertebrae.

SUMMARY

The present disclosure relates to a threadless, generally barrel-shapedfusion implant apparatus for facilitating fusion of adjacent bonestructures. The apparatus includes an implant member which is positionedbetween adjacent opposed bone structures. The implant member defines alongitudinal axis and first and second longitudinal ends and has anouter wall which is dimensioned to engage the opposed bone structuresupon positioning therebetween in supporting relation therewith.Preferably, the outer wall defines an internal cavity for the receptionof bone growth inducing substances and includes a plurality of apertureswhich extend therethrough in communication with the internal cavity topermit fusion of vertebral bone tissue. The implant member also includesan intermediate portion which defines a cross-sectional dimensiontransverse to the longitudinal axis which is greater than therespective, corresponding cross-sectional dimensions of the first andsecond longitudinal ends of the implant member. Preferably, the implantmember is symmetrically arranged about its medial axis to provide thegeneral, barrel-shape or appearance.

The barrel-shaped fusion cage is configured for stable insertion withina space between adjacent vertebrae. The fusion cage may include at leastone concave wall portion to facilitate lateral or side-by-side insertionwith a second cage between adjacent vertebrae.

The present disclosure also relates to a method for fusing adjacentvertebrae which includes the steps of: 1) providing a threadless implantmember which defines a longitudinal axis and first and secondlongitudinal ends, and has a cross-sectional dimension transverse to thelongitudinal axis greater than the respective correspondingcross-sectional dimensions of the first and second longitudinal ends ofthe implant member; 2) accessing the intervertebral space definedbetween adjacent vertebrae; 3) advancing the implant member within theintervertebral space such that the first and second longitudinal endsare adjacent respective anterior and posterior sections of the adjacentvertebrae; and 4) permitting bone growth into contacting surfaces of theimplant member to facilitate fusion of the adjacent vertebrae.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a fusion cage according to the presentdisclosure;

FIG. 2 is a side view of the fusion cage shown in FIG. 1;

FIG. 3A is a side view of the fusion cage of FIG. 1 illustrating a bulgepositioned along a medial axis “m”;

FIG. 3B is a cross-sectional view of the fusion cage taken along sectionline 3B-3B of FIG. 3A;

FIG. 4A is a lateral view illustrating a pair of cylindrically-shapedprior art fusion implants positioned within the intervertebral space forfusion of adjacent vertebrae;

FIG. 4B is a top view showing a side-by-side orientation of two priorart cylindrically-shaped fusion cages between two adjacent vertebrae;

FIG. 5A is a lateral view showing the placement of the fusion cage ofFIG. 1 between two adjacent vertebrae;

FIG. 5B is a top view showing a pair of fusion implants according to thepresent disclosure positioned within the intervertebral space for fusionof adjacent vertebrae;

FIG. 6A is a perspective view of an alternate embodiment of the fusioncage according to the present disclosure;

FIG. 6B is a end view of the fusion cage of FIG. 6A;

FIG. 6C is a view illustrating a pair of the implants of FIG. 6Ainserted within an intervertebral space;

FIG. 7A is a perspective view of an alternate embodiment of the fusioncage according to the present disclosure; and

FIG. 7B is a end view of the fusion cage of FIG. 7A.

DETAILED DESCRIPTION

Referring now to the drawings in which like reference numerals identifysimilar or identical elements throughout the several views, FIGS. 1-3illustrate one embodiment of the fusion cage implant according to thepresent disclosure. Fusion implant 10 includes a generally elongatedbody 12 having a proximal end 13 and a distal end 14. In the drawingsand in the description which follows, the term “proximal”, as istraditional, will refer to the end of the cage 10 which is closer to thesurgeon, while the term “distal” will refer to the end which is furtherfrom the surgeon. Preferably, cage 10 is fabricated from a suitablebiocompatible rigid material such as titanium and/or alloys of titanium,stainless steel, ceramic materials or rigid polymeric materials.Moreover, it is envisioned that cage 10 is sufficient in strength to atleast partially replace the supporting function of an intervertebraldisc, i.e., to maintain adjacent vertebrae in desired spaced relation,during healing and fusion. Cage 10 is preferably provided in variouslengths ranging from about 24 mm to about 28 mm for example.

As best shown in FIGS. 1, 2 and 3A, the body 12 of cage 10 includes anouter wall 15 which encloses an inner cavity 18 defined within theinterior of the cage body 12. Inner cavity 18 accommodates bony ingrowthsubstances which induce the soft cancellous bone surrounding thevertebrae to grow inwardly towards the contact surfaces of the fusioncage 10 to stabilize the cage 10 between two adjacent vertebrae 202, 204(FIG. 5A). Outer wall 15 is generally barrel-shaped along a longitudinalaxis “A” which extends from proximal end 13 to distal end 14 (FIG. 2)and includes a bulge 19 generally positioned midway therebetween. Asexplained in more detail below, it is envisioned that the barrel-likeshape of cage 10 increases the overall strength and load sharingcapacity of the cage 10, tends to reduce “stiffness” which has beenassociated with other prior art designs and allows more bone graftsubstances to be packed into the augmented internal volume of the cage10 which it is believed will further enhance bone fusion. It is alsoenvisioned that this configuration provides a greater surface area ofthe implant so as to facilitate contacting engagement and support of theimplant with the adjacent vertebrae 202, 204 (FIG. 5A).

As best shown in FIGS. 3A and 3B, the major dimension of “B” alonglongitudinal axis “A” varies from a minimum dimension “B_(min)”proximate the ends 13, 14 of cage body 12 to a bulge section 19 having amaximum dimension “B_(max)” generally disposed midway between ends 13,14 along a medial axis “m”. More specifically, body 12 of cage 10 issymmetrically arranged about medial axis “m” whereby the maximumdiameter or cross-sectioned dimension B_(max) extends about the medialaxis “m” and progressively decreases to the proximal and distal ends 13,14. Preferably, the maximum diameter or dimension “B_(max)” ranges fromabout 12 mm to about 20 mm and the minimum diameter or dimension“B_(max)” ranges from about 13 mm to about 19 mm. In the preferredembodiment, the maximum diameter is 17.5 mm and the minimum diameter is16 mm. The length is 21 mm. Other dimensions are also contemplated.

As can be appreciated, this gives cage 10 its barrel-like or bulge-likeappearance. It is envisioned that dimensioning the cage 10 in thisfashion has several distinct advantages: 1) the barrel-like cage is aninherently stronger pressure vessel than a simple cylinder design, i.e.,the barrel-like cage has a higher compressive strength, exhibits greaterresistance to fatigue and possesses a higher yield load; 2) thebarrel-like shape promotes a better anatomical fit between adjacentvertebrae 202, 204 in both the transverse plane (Compare FIG. 4B withFIG. 5B) and the sagittal plane (Compare FIG. 4A with FIG. 5A); 3) thelow profile ends 13, 14 facilitate insertion of the cage 10 and allowtwo cages 10 to be placed side-by-side with reduced overhang 125 outsidethe periphery of the vertebral bodies 202 (Compare FIG. 4B with FIG.5B); 4) the center bulge 19 enhances retention of the cage 10 oncepositioned between the vertebral bodies 202, 204; and 5) the barrel-likeshape of the cage 10 results in an increase in the internal volume ofthe cage 10 which accommodates additional bone growth inducingsubstances and enables more bone to grow into the cage 10, thusenhancing bone-to-cage fusion. The barrel cage also exhibits a higherexpulsion load, i.e., the force required to eject the cage from theintervertebral space.

With reference to FIGS. 1 and 2, the surface of outer wall 15 ispreferably non-threaded or threadless. The term “threadless” is definedherein to mean that the outer wall 15 is devoid of any threads whichwould require rotation of the cage 10 upon positioning between theadjacent vertebrae 202, 204. It is envisioned that the surface of outerwall 15 may be coated with a variety of different materials whichfacilitate insertion of the cage 10 and enhance retention of the cage 10within the pre-drilled cavity “I”.

As stated above, it is also envisioned that cage 10 can be dimensionedsuch that cage 10 is generally symmetrical about axis “A”, i.e.,front-to-end symmetry, which will permit insertion of the cage 10 fromeither the proximal or distal end 13, 14, respectively.

As best shown in FIGS. 1 and 2, a plurality of apertures 22 extendthrough outer wall 15 of cage body 12 and preferably promote immediatebone to bone contact between the vertebral bodies 202, 204 and the boneinducing substances packed within the internal cavity 18 of the cagebody 12. Such arrangement of apertures 22 is disclosed in commonlyassigned U.S. Pat. Nos. 4,961,740 and 5,026,373, the contents of whichare hereby incorporated by reference. Apertures 22 are preferablysubstantially the same in dimension although it is envisioned that thedimensions of the apertures 22 may vary to provide for more or lessbone-to-bone contact depending upon a particular purpose.

Preferably, apertures 22 are oriented such that when the cage 10 isinserted between vertebrae, a majority of apertures 22 contact the upperand lower vertebral bone structures 202, 204 to encourage bony ingrowththrough cage body 12 from the vertebral bone structures 202, 204.

FIG. 6A shows an alternate embodiment of the fusion cage 100. Moreparticularly, outer wall 115 of cage body 112 includes at least one sidecut-out or concave wall portion 120 which extends parallel tolongitudinal axis “A” along outer wall 115 generally from the proximalend 113 to the distal end 114. Preferably, two side cut-outs 120 aredisposed along outer wall 115 in diametrically opposing relation to oneanother to reduce the effective dimension or diameter of cage 100transversally relative to longitudinal axis “A”. In either case, thedisposition of the side cut-out(s) 120 enhance the low profile featuresof the present disclosure and facilitate insertion of the cage 100between the adjacent vertebral bodies 202, 204. Side cut-outs 120 ofcage 112 preferably do not include apertures 122 in order to preventgrowth of disc material which might interfere with the overall bonefusing process as will be discussed.

Preferably and as shown in FIGS. 6A and 6B, side cut-outs 120 of body112 provide a generally elliptical configuration or appearance to cage100 defining a major dimension “B” which is greater than a minordimension “C”. It is envisioned that this configuration provides agreater surface area of the implant so as to facilitate contactingengagement and support of the implant with the adjacent vertebrae 202,204. Other dimensions are also contemplated. Preferably, the sidecut-outs 120 are disposed along the minor axis “C” to enhance the lowprofile features of cage 100 and facilitate insertion.

As can be appreciated, the low profile ends 113, 114 and the sidecut-outs 120 facilitate insertion of the cage 100 and allow two cages100, 100 to be placed side-by-side with a reduced overhang 125 outsidethe periphery of the vertebral bodies 202, 204 as illustrated in FIG.6CB.

FIGS. 7A and 7B show another embodiment of the fusion cage 200. Moreparticularly, outer wall 215 of cage body 212 includes at least one sidecut-out or concave wall portion 220 which extends parallel tolongitudinal axis “A” along outer wall 215 generally from the proximalend 213 to the distal end 214. Preferably, the side cut-out 220 includesat least one mechanical interface, e.g., a tongue 230, which is designedto cooperate with a corresponding mechanical interface, e.g., a groove232, disposed on a second implant member 200 to unite two implantmembers 200, 200 in lateral side-by-side relation between adjacentvertebral bodies 202, 204. It is envisioned that side cut-out 220 can bedimensioned to include both a tongue 230 and a groove 232 interfacedisposed on opposite edges thereof which mechanically engagecorresponding tongue 230 and groove 232 interfaces disposed on a secondimplant member 200.

As can be appreciated, implant 200 can also be dimensioned to includediametrically-opposing side cut-outs 220 each having tongue 230 andgroove 232 interfaces oppositely oriented on respective edges thereof tofacilitate insertion and mechanical engagement of the two implantmembers 200, 200 during insertion. It is envisioned that othermechanical interfaces may also be employed along the side cut-outs 220to unite the two implants 200 during insertion, e.g., dovetail, mortiseand tenon, etc.

The present disclosure also relates to a method of inserting athreadless, barrel-like fusion cage 10 into an intervertebral space “I”defined between adjacent vertebrae 202, 204. The method discussedhereinafter will generally relate to an open antero-lateral approach forspinal fusion implant insertion. However, as can be appreciated, otherspinal implant procedures are also contemplated, e.g., posterior, directanterior, etc. Laparoscopic approaches are also envisioned.

Initially, one lateral side of an intervertebral space “I” between thetwo vertebral bodies 202, 204 is accessed utilizing appropriateretractors (not shown) to expose the anterior vertebral surface.Thereafter, the retractor is inserted within the intervertebral space“I” from an antero-lateral or oblique position with relation to thevertebral bodies 202, 204. Such an approach provides advantages withregard to avoiding vessels and ligaments.

Upon insertion of the retractor, the vertebral bodies 202, 204 aredistracted whereby the retractor becomes firmly lodged within theintervertebral space “I”. A drilling instrument is now utilized toprepare the disc space and vertebral bodies 202, 204 for insertion ofthe fusion cage 10. Preferably, the cutting depth of drilling instrumentcan be readily adjusted to correspond to the length of the fusion cage10. As can be appreciated, as the drilling instrument is advanced intothe intervertebral space “I”, the surrounding soft tissue is sheared andthe bone of the adjacent vertebrae 202, 204 is cut thereby forming abore which extends into the adjacent vertebrae 202, 204.

The fusion cage 10 of FIG. 1 is then packed with bone growth inducingsubstances as in conventional in the art and then mounted on aninsertion instrument (not shown) and driven between the adjacentvertebral bodies 202, 204. As mentioned above, it is envisioned that thelow profile proximal and distal ends, 13 and 14, respectively, alongwith the center bulge 19 facilitate insertion and retention of the cage10. Moreover, the low profile ends 13 and 14 of cage body 12 allow twocages to be placed closer together decreasing the likelihood of cage 10overhang.

Cage 10 is then released from the mounting instrument which issubsequently removed from the disc area.

Thereafter, a second lateral side of the intervertebral space “I” isaccessed and the above-described process is repeated to insert a secondcage 10 in lateral side-by-side relation as shown in FIG. 5B. Asappreciated, the cages 10 are arranged such that the cages 10, 10 residein adjacent side-by-side relation.

As can be appreciated, fusion cages 10 form struts across theintervertebral space “I” to maintain the adjacent vertebrae 202, 204 inappropriate spaced relation during the fusion process. Over a period oftime, the adjacent vertebral tissue communicates through apertures 22within cages 10, 10 to form a solid fusion. It is envisioned that thebarrel-like shape of each fusion cage 10 is inherently stronger that acylinder-shaped fusion cage and provides a better anatomical fit betweenadjacent vertebrae 202, 204. For example and as best shown a comparisonof FIGS. 4B and 5B, the prior art cylindrically-shaped fusion cages 100,100 when positioned in side-by-side relation tend to overhang theintervertebral space “I” at point 225 wherein the barrel-like fusioncages 10, 10 when positioned in the same manner have a reduced overhang125 thus providing a better anatomical fit within the intervertebralspace “I”.

The same procedure is followed in connection with insertion of theimplants 100 and 200 of FIGS. 6A, 6B [and 7A, 7B], respectively. Forexample and with respect to the implant 100 of FIGS. 6A and 6B, uponinsertion the two cages 100, 100 are arranged such that respective sidecut-out portions 120 of each cage 100 are disposed in lateralside-by-side relation and not in contact with the adjacent vertebralbodies 202, 204. Alternatively, the cages 10 may be positioned such thatthe curved body of one cage is received within the side cut 120 of theother cage to further reduce the profile of implanted cages as depictedin FIG. 6C. As indicted above, side cut-out portions 120 are devoid ofapertures 122 thereby permitting only direct bone growth or passagethrough the apertures 122 of the cage body portion contacting theadjacent vertebrae 202, 204.

With respect to implant 200 of FIGS. 7A and 7B, the two cages 200, 200are arranged in the same manner as described above with respect toimplant 100 with the exception that the two implants 200, 200 aredimensioned to mechanically engage one another upon insertion. Moreparticularly and as described above, upon insertion the tongue 230 andgroove 232 interface of the side cut-out 220 of the first implant 200 isdimensioned to slidingly engage a corresponding tongue 230 and groove232 interface of the side cut-out 220 of the second implant 200 tosecure the two implants 200, 200 in lateral side-by-side relationbetween adjacent vertebral bodies 202, 204. As mentioned above, othermechanical interfaces can be employed to mechanically unite the twoimplants 200, 200 once disposed between adjacent vertebral bodies 202,204.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. For example, it is envisioned that a series of aperturescould be drilled at one end of the cage 10 which would allow a surgeonto use a smaller tang and smaller drill thereby preserving more of theposterior elements of the spine during the operation.

While the above description contains many specifics, these specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision other modifications within the scopeand spirit of the claims appended hereto.

1. A fusion implant apparatus for facilitating fusion of adjacent bonestructures, which comprises an elongate implant member for positioningbetween adjacent opposed bone structures, the implant member defining alongitudinal axis extending along its length and first and secondlongitudinal ends, and having an outer wall dimensioned to engage theopposed bone structures upon positioning therebetween in supportingrelation therewith, the outer wall defining an internal cavity forreception of bone growth inducing substances and including a pluralityof apertures extending therethrough in communication with the internalcavity to permit fusion of vertebral bone tissue, the implant memberhaving an intermediate portion between the first and second longitudinalends with a girth relative to the longitudinal axis which is greaterthan the girths of the first and second longitudinal ends, theintermediate portion having an arcuate lengthwise shape and a roundedcross-section in a plane perpendicular to the longitudinal axis.
 2. Thefusion implant apparatus according to claim 1 wherein the girth of theimplant member increases from each of the first and second ends towardthe intermediate portion.
 3. The fusion implant apparatus according toclaim 2 wherein the girths of the first and second ends aresubstantially equal.
 4. The fusion implant apparatus according to claim3 wherein the implant member is substantially symmetric about a planewhich bisects its length.
 5. The fusion implant apparatus according toclaim 4 wherein the intermediate portion has a substantially circularcross-section in a plane perpendicular to the longitudinal axis.
 6. Thefusion implant apparatus according to claim 1 wherein the outer wall ofthe implant member includes at least one concave wall portion extendingalong its length.
 7. The fusion implant apparatus according to claim 6wherein the outer wall includes opposed concave wall portions.
 8. Thefusion implant apparatus according to claim 1 wherein the implant memberis dimensioned and configured for insertion between adjacent vertebrae.9. A fusion implant apparatus for facilitating fusion of adjacentvertebrae, which comprises: an elongate implant member dimensioned forpositioning between adjacent vertebrae to support the adjacent vertebraein spaced relation, the implant member defining a longitudinal axisextending along its length and first and second longitudinal ends, andhaving an outer wall constructed to engage the adjacent vertebrae uponpositioning therebetween, the outer wall defining an internal cavity forreception of bone growth inducing substances, the implant member havingan intermediate portion between the first and second longitudinal endswith a girth relative to the longitudinal axis greater than the girthsof the first and second longitudinal ends of the implant member, theintermediate portion having an arcuate lengthwise shape and a roundedcross-section in a plane perpendicular to the longitudinal axis, theouter wall having a plurality of apertures extending therethrough incommunication with the internal cavity to permit fusion of vertebralbone tissue.
 10. The fusion implant apparatus according to claim 9wherein the girth of the implant member increases from each of the firstand second ends toward the intermediate portion.
 11. The fusion implantapparatus according to claim 10 wherein the implant member issubstantially symmetric about a plane which bisects its length, wherebythe girth of the implant member decreases toward each of the first andsecond longitudinal ends.
 12. The fusion implant apparatus according toclaim 9 wherein the outer wall of the implant member includes at leastone concave wall surface portion extending along its length.
 13. Amethod for fusing adjacent vertebrae, comprising the steps of: providingan elongate implant member defining a longitudinal axis extending alongits length and first and second longitudinal ends, the implant memberhaving an intermediate portion between the first and second longitudinalends with a girth relative to the longitudinal axis which is greaterthan the girths of the first and second longitudinal ends of the implantmember, the intermediate portion having an arcuate lengthwise shape anda rounded cross-section in a plane perpendicular to the longitudinalaxis; accessing the intervertebral space defined between adjacentvertebrae; advancing the implant member within the intervertebral spacesuch that the first and second longitudinal ends are adjacent respectiveanterior and posterior sections of the adjacent vertebrae; andpermitting bone growth into contacting surfaces of the implant member tofacilitate fusion of the adjacent vertebrae.
 14. The method of claim 13wherein the implant member includes an exterior wall defining aninternal cavity and having apertures extending therethrough and furtherincluding the step of providing a bone growth inducing substance withinthe internal cavity and permitting bony tissue of the adjacent vertebraeto grow through the apertures to communicate with the bone growthinducing substance.